title: Eszopiclone for the treatment of posttraumatic stress disorder and associated insomnia: a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  The development of novel strategies for the treatment of posttraumatic stress disorder (PTSD) represents a critical public health need. We present the first prospective, randomized, double-blind, placebo-controlled trial of a non-benzodiazepine hypnotic agent for the treatment of PTSD and associated insomnia.
  
  
  METHODS
  Twenty-four patients with PTSD by DSM-IV criteria and sleep disturbance were treated in a randomized, double-blind, placebo-controlled crossover study of 3 weeks of eszopiclone 3 mg at bedtime compared to placebo. The primary outcome measures were changes in scores on the Short PTSD Rating Interview (SPRINT) and the Pittsburgh Sleep Quality Index (PSQI). The data were collected from April 2006 to June 2008.
  
  
  RESULTS
  Three weeks of eszopiclone pharmacotherapy was associated with significantly greater improvement than placebo on PTSD symptom measures including the SPRINT (P = .032) and the Clinician-Administered PTSD Scale (P = .003), as well as on measures of sleep including the PSQI (P = .011) and sleep latency (P = .044). Greater improvement with eszopiclone on PTSD measures was present even when specific sleep-related items were excluded. Adverse events were consistent with the known profile of the drug.
  
  
  CONCLUSIONS
  This study provides initial evidence that pharmacotherapy with eszopiclone may be associated with short-term improvement in overall PTSD severity as well as associated sleep disturbance. Longer, more definitive study of eszopiclone in PTSD is warranted.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00120250.
authors.affiliation: Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital, One Bowdoin Square, Sixth Floor, Boston, MA 02114, USA. mpollack@partners.org
authors.forename: Mark H
authors.initials: MH
authors.lastname: Pollack
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Hoge
authors.forename: John J
authors.initials: JJ
authors.lastname: Worthington
authors.forename: Samantha J
authors.initials: SJ
authors.lastname: Moshier
authors.forename: Rachel S
authors.initials: RS
authors.lastname: Wechsler
authors.forename: Mina
authors.initials: M
authors.lastname: Brandes
authors.forename: Naomi M
authors.initials: NM
authors.lastname: Simon
mesh_terms: D000328:Adult; D000553:Ambulatory Care; D053961:Azabicyclo Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D015897:Comorbidity; D018592:Cross-Over Studies; D004311:Double-Blind Method; D000069582:Eszopiclone; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010552:Personality Assessment / Q000706:statistics & numerical data; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011594:Psychometrics; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D013313:Stress Disorders, Post-Traumatic / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D053961:Azabicyclo Compounds; D006993:Hypnotics and Sedatives; D010879:Piperazines; D000069582:Eszopiclone